NCT01460095

Brief Summary

Glycated haemoglobin (HbA1c) is the best surrogate of average blood glucose control in diabetic patients. Large-scale studies in the USA and UK have demonstrated that lowering HbA1c significantly reduces diabetes complications. Moreover, immediate feedback of HbA1c measurement to patients improves control. However, HbA1c is unavailable in most parts of Africa, a continent with one of the highest burden of diabetes. To translate these evidences, the investigators will provide affordable access to HbA1c measurement and relevant education in 2 African countries aiming significant improvement of diabetes control. The investigators will develop with local health authorities, training and cost-recovery scheme for long-term sustainability.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,349

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2.7 years

First QC Date

October 23, 2011

Last Update Submit

April 16, 2016

Conditions

Diabetes Mellitus

Keywords

diabetestranslational researchHbA1ceducation

Outcome Measures

Primary Outcomes (1)

  • one year change in glycated haemoglobin (HbA1c)

    Baseline to 12 months individual change in HbA1c level

    Baseline and 12 months

Secondary Outcomes (2)

  • One-year change in proportion of patients reaching HbA1c targets

    Baseline and 12 months

  • One-year change in urinary albumin excretion

    Baseline and 12 months

Study Arms (1)

HbA1c measurement and education

EXPERIMENTAL

3-monthly Hba1c determination with immediate feedback and targeted education delivered to all participants

Other: HbA1c measurement and education

Interventions

HbA1c measurement and educationOTHER

three-monthly point of care measurement of HbA1c with immediate feedback to patients and provision of interpretation and targeted one-to-one education

HbA1c measurement and education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diabetes mellitus irrespective of type
  • Adult age (18 years and over)

You may not qualify if:

  • Individuals planning to migrate from study sites within one year
  • Any intercurrent acute illness
  • Enrollment in any other concomitant intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Location

Garoua Regional Hospital

Garoua, North Region, Cameroon

Location

Bamenda Regional Hospital

Bamenda, North-West Region, Cameroon

Location

Buea Regional Hospital

Buea, South-West Region, Cameroon

Location

Bafoussam District Hospital

Bafoussam, Cameroon

Location

Boke Regional Hospital

Boké, Guinea

Location

CHU Donka

Conakry, Guinea

Location

Kankan Regional Hospital

Kankan, Guinea

Location

Labe regional Hospital

Labé, Guinea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Eugene Sobngwi, MD, PhD

    Newcastle University, UK and Yaounde Central Hospital, Cameroon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer and Consultant Physician

Study Record Dates

First Submitted

October 23, 2011

First Posted

October 26, 2011

Study Start

March 1, 2009

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CA(5)GU(4)